Cook
This article was originally published in The Gray Sheet
Executive Summary
PATENCY trial of Cook's Logic PTX paclitaxel-eluting stent gets FDA go-ahead for enrollment of an additional 200 patients at 20 sites. Fifty patients have already entered the trial, placed on hold last fall while the company responded to FDA questions about the protocol (1"The Gray Sheet" Nov 19, 2001, p. 17). The firm maintains its prediction for a domestic launch of the stent in 2003, and separately announces IDE approval for a 100-patient pilot trial of the Logic PTX for restenosis in a previously implanted stent. European launch of the Logic PTX is on schedule for this spring following the Jan 18 filing for CE mark. In October 2001, J&J/Cordis filed for CE mark of its rivalCypher sirolimus-eluting stent as well...